Intra-lesional Nivolumab Therapy for Limited Cutaneous Kaposi Sarcoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- HIV/AIDS
- Immunosuppression
- Kaposi Sarcoma
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Standard 3+ 3 design during the initial safety cohort, then expansion cohortMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Infection with Kaposi sarcoma herpesvirus (KSHV, or human herpesvirus-8 (HHV-8)) causes Kaposi sarcoma (KS). These virally associated diseases occur more frequently in HIV-infected individuals, but can also be found in HIV-uninfected population. Evolution of immunosuppressive mechanisms presumably p...
Infection with Kaposi sarcoma herpesvirus (KSHV, or human herpesvirus-8 (HHV-8)) causes Kaposi sarcoma (KS). These virally associated diseases occur more frequently in HIV-infected individuals, but can also be found in HIV-uninfected population. Evolution of immunosuppressive mechanisms presumably plays a permissive role in the development, progression and recurrence of these virus-associated cancers and pre-cancers. Currently, available treatment options for these lesions are imperfect. The goal of this study is to determine whether intra-lesional injections of nivolumab can enhance specific T cell responses in vitro and enhance activity against these virus-associated lesions. Chronic viral infections generate "exhausted" CD8+ T cells with a diminished capacity to produce cytokines and to lyse infected cells. The PD-1 (program death-1)/PD-L1 (program death ligand-1) pathway implicated in the balance between immune eradication and immune escape. This study will evaluate the safety, tolerability, and potential benefits of injecting nivolumab into KS in HIV-infected and HIV-uninfected individuals every 2 weeks for total of 4 doses. The investigators believe this mode of treatment is feasible and tolerable by avoiding the systemic autoimmune adverse events caused by systemic injection of nivolumab.
Tracking Information
- NCT #
- NCT03316274
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Principal Investigator: Chia-ching Wang, MD University of California, San Francisco